Back to resultsData Registry Following Patients Using Supera Stent in the Femoral Arteries (STRONG)
Primary Purpose
Peripheral Artery Disease, Femoropopliteal Artery Stenosis, Peripheral Vascular Disease
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
SUPERA Interwoven self-expanding nitinol stent
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Artery Disease focused on measuring Femoral artery stenosis, Peripheral vascular Disease
Eligibility Criteria
Exclusion Criteria:
(Clinical)
- Patient or legal guardian understands registry procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies. (Note: Retrospective data may be collected and entered into the EDC system after a fully executed informed consent has been provided).
- Rutherford-Becker classification 2 through 5 only
- Patient is at least 18 years of age and of legal age of consent.
- Patient must be willing to participate in the registry for at least 5 years.
(Angiographic)
- Target lesion is a single de novo or restenotic (outside a stent) SFA or Popliteal artery lesion ≥ 1 cm from origin of another stent; additional lesions may be present., but there is only one target lesion
- All SFA target lesions are to be located with the proximal point at least 2 cm below the origin of the profunda femoris artery.
- All Popliteal Artery target lesions are to be located with the most distal point at least 1 cm proximal to the bifurcation of the anterior tibial artery and the tibioperoneal trunk.
- Target lesion length 1-20 cm (visual estimate)
- Target lesion stenosis ≥50% (visual estimate)
- Popliteal artery patent if the lesion is in the SFA
- SFA patent if the lesion is in the popliteal artery
- At least one widely patent (< 50% stenosis) infrapopliteal artery (for distal run-off)
Exclusion Criteria:
(Clinical)
- Evidence of heparin induced thrombocytopenia (HIT), or intravenous tPA, Plavix, Ticlid, or aspirin therapy sensitivities
- Patient is participating in a clinical study that could confound results
- Patient is pregnant/breastfeeding at time enrollment or plans to become pregnant during the course of participation in the registry.
(Angiographic)
- Target lesion length > 20 cm
- Instent restenotic / reoccluded target lesion
- Acute (≤ 4 weeks) thrombotic occlusion
- Untreated ipsilateral pelvic stenosis
Sites / Locations
- Herzzentrum Abteilung fur Angiologie
- Heart Center Leipzig/Park Hospital
- Kathlisches Klinikum Mainz
- Zentrum fur Diabetes-und GefaBerkrankungen
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Device SUPERA Stent
Arm Description
SUPERA Interwoven Self-Expanding Nitinol Stent System
Outcomes
Primary Outcome Measures
Six-minute Walking Distance
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Six-minute Walking Distance
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Six-minute Walking Distance
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Six-minute Walking Distance
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Secondary Outcome Measures
Number of Participants Experiencing Peri-procedural and Post-procedural Complications
Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.
Number of Peri-procedural and Post-procedural Complications
Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.
Rutherford-Becker Clinical Category
Rutherford/Becker Categories:
0 - Asymptomatic, no hemodynamically significant occlusive disease.
- Mild claudication.
- Moderate claudication.
- Severe claudication.
- Ischemic rest pain.
- Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia.
- Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.
Restenosis by Duplex Ultrasound
In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.
Restenosis by Duplex Ultrasound
In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.
Target Lesion Revascularization
Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Target Lesion Revascularization
Target Vessel: The entire vessel in which the treated lesion is located. The boundaries for the iliac artery are the abdominal aortic bifurcation and the superior border of the inguinal ligament.
Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion.)
Stent Fracture
Stent fractures determined by fluoroscopy .
Stent Fracture
Stent fracture and Involuntary stent migration are types of device System Failure.
Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.
Stent Fracture
Stent fracture and Involuntary stent migration are types of device System Failure.
Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.
Target Limb Ankle Brachial Index (at Rest)
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Target Limb Ankle Brachial Index (at Rest)
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Target Limb Ankle Brachial Index (at Rest)
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Target Limb Ankle Brachial Index (at Rest)
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Target Limb Ankle Brachial Index (at Rest)
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Six-minute Walking Distance
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01154751
Brief Title
Data Registry Following Patients Using Supera Stent in the Femoral Arteries
Acronym
STRONG
Official Title
Supera Treatment Registry Observing Neointimal Growth
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment,increased loss to follow-ups and general lack of interest.
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or femoropopliteal arteries.
Detailed Description
This registry follows up to 200 patients for at least 5 years.
The STRONG Data Registry will follow patients under real world conditions, evaluating restenosis rates, periprocedural/postprocedural complications, patency, target lesion revascularization, walking distance, stent fractures, and adverse events/serious adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease, Femoropopliteal Artery Stenosis, Peripheral Vascular Disease
Keywords
Femoral artery stenosis, Peripheral vascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device SUPERA Stent
Arm Type
Other
Arm Description
SUPERA Interwoven Self-Expanding Nitinol Stent System
Intervention Type
Device
Intervention Name(s)
SUPERA Interwoven self-expanding nitinol stent
Intervention Description
Insertion of stent at stenotic area
Primary Outcome Measure Information:
Title
Six-minute Walking Distance
Description
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Time Frame
At baseline
Title
Six-minute Walking Distance
Description
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Time Frame
30 days
Title
Six-minute Walking Distance
Description
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Time Frame
6 months
Title
Six-minute Walking Distance
Description
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Number of Participants Experiencing Peri-procedural and Post-procedural Complications
Description
Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.
Time Frame
30 days
Title
Number of Peri-procedural and Post-procedural Complications
Description
Periprocedural/Postprocedural Complications defined as complications during the procedure through 30 days post implant that include hematoma, arteriovenous (AV) fistula pseudoaneurysm, subacute occlusion, non-target lesion Percutaneous Transluminal Angioplasty (PTA) /stenting, distal embolization, and vessel perforation.
Time Frame
30 days
Title
Rutherford-Becker Clinical Category
Description
Rutherford/Becker Categories:
0 - Asymptomatic, no hemodynamically significant occlusive disease.
- Mild claudication.
- Moderate claudication.
- Severe claudication.
- Ischemic rest pain.
- Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia.
- Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable.
Time Frame
30 days
Title
Restenosis by Duplex Ultrasound
Description
In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.
Time Frame
6 months
Title
Restenosis by Duplex Ultrasound
Description
In-Stent Restenosis is re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasonography (DUS) or arteriography. A peak systolic velocity ratio (PSVR) of 2.4 and 2.5 will be used to calculate duplex restenosis.
Time Frame
1 Year
Title
Target Lesion Revascularization
Description
Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time Frame
6 months
Title
Target Lesion Revascularization
Description
Target Vessel: The entire vessel in which the treated lesion is located. The boundaries for the iliac artery are the abdominal aortic bifurcation and the superior border of the inguinal ligament.
Target Lesion Revascularization (TLR): Any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion.)
Time Frame
1 Year
Title
Stent Fracture
Description
Stent fractures determined by fluoroscopy .
Time Frame
1 Year
Title
Stent Fracture
Description
Stent fracture and Involuntary stent migration are types of device System Failure.
Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.
Time Frame
1 to 2 years
Title
Stent Fracture
Description
Stent fracture and Involuntary stent migration are types of device System Failure.
Device System Failure is defined as the inability of the device to provide the intended clinical utility requiring surgical intervention to correct.
Time Frame
1 to 3 Years
Title
Target Limb Ankle Brachial Index (at Rest)
Description
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Time Frame
At baseline
Title
Target Limb Ankle Brachial Index (at Rest)
Description
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Time Frame
30 days
Title
Target Limb Ankle Brachial Index (at Rest)
Description
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Time Frame
6 months
Title
Target Limb Ankle Brachial Index (at Rest)
Description
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Time Frame
1 Year
Title
Target Limb Ankle Brachial Index (at Rest)
Description
Ankle Brachial Index (ABI) is a measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms. A doppler probe is used to monitor the pulse while a sphygmomanometer is inflated above the artery. The cuff is deflated and the pressure at which the pulse returns is recorded.
ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure
The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.
Time Frame
2 Years
Title
Six-minute Walking Distance
Description
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
Time Frame
2 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Exclusion Criteria:
(Clinical)
Patient or legal guardian understands registry procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies. (Note: Retrospective data may be collected and entered into the EDC system after a fully executed informed consent has been provided).
Rutherford-Becker classification 2 through 5 only
Patient is at least 18 years of age and of legal age of consent.
Patient must be willing to participate in the registry for at least 5 years.
(Angiographic)
Target lesion is a single de novo or restenotic (outside a stent) SFA or Popliteal artery lesion ≥ 1 cm from origin of another stent; additional lesions may be present., but there is only one target lesion
All SFA target lesions are to be located with the proximal point at least 2 cm below the origin of the profunda femoris artery.
All Popliteal Artery target lesions are to be located with the most distal point at least 1 cm proximal to the bifurcation of the anterior tibial artery and the tibioperoneal trunk.
Target lesion length 1-20 cm (visual estimate)
Target lesion stenosis ≥50% (visual estimate)
Popliteal artery patent if the lesion is in the SFA
SFA patent if the lesion is in the popliteal artery
At least one widely patent (< 50% stenosis) infrapopliteal artery (for distal run-off)
Exclusion Criteria:
(Clinical)
Evidence of heparin induced thrombocytopenia (HIT), or intravenous tPA, Plavix, Ticlid, or aspirin therapy sensitivities
Patient is participating in a clinical study that could confound results
Patient is pregnant/breastfeeding at time enrollment or plans to become pregnant during the course of participation in the registry.
(Angiographic)
Target lesion length > 20 cm
Instent restenotic / reoccluded target lesion
Acute (≤ 4 weeks) thrombotic occlusion
Untreated ipsilateral pelvic stenosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Zeller, Prof Dr med
Organizational Affiliation
Herzzentrum Abteilung fur Angiologie, Bad Krozingen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzzentrum Abteilung fur Angiologie
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Heart Center Leipzig/Park Hospital
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Kathlisches Klinikum Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Zentrum fur Diabetes-und GefaBerkrankungen
City
Munster
ZIP/Postal Code
48145
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Data Registry Following Patients Using Supera Stent in the Femoral Arteries
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